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BD Pyxis recallZ-1639-2025 · CareFusion 303, Inc. · initiated Mar 11, 2025

Class II Open, Classified All recalls posted in April 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

FDA root cause category: Software design

What the company is doing

On 3/11/2025, correction notices were mailed and emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Lab Manager, Clinical Engineering, and other customers asking them to take the following actions: 1) Best practice is to verify the total dose being removed is accurate against the provider's order, and if available utilize barcode medication administration as an additional check to ensure the correct dose is retrieved prior to administration. 2) Customers can inventory the CUBIE pocket via a cycle count or blind count to correct the inventory when discrepancies occur. Customers can refer to the BD Pyxis MedBank Cabinet User Guide - 10000414987 Ver. 01, Version v2.4 for instructions. Refer to chapter six (6), page 103. 3)Customers should ensure backup procedures (which may include but are not limited to keys, emergency medication supplies, alternate devices in proximity, etc) are in place and staff have all been properly educated on them. 4) Share this letter with any facilities within your network that you may have distributed affected devices to. 5) Post this Recall Letter on or near affected products as a reminder of the recall and the steps/instructions that are needed to be followed. 6) Complete and return the Response Form via email to [email protected] Firm is in the process of contacting all customers to schedule an appropriate time for the software upgrade to MedBank software version 1.7. If you require further assistance contact the firm's Technical support: 1-866-930-9251 Phone Hours: 24 hours, 7 days a week Website: https://bdx.my.site.com/CC360/s/impactedproducts?rn=MMS-24-5163/MMS-25-5183/5184

Recall details

Recall number
Z-1639-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Mar 11, 2025
Posted by the FDA
Apr 18, 2025
Recalling firm
CareFusion 303, Inc.
Quantity
7,357
Product code
BRY
Distribution
US Nationwide distribution including in the states of MO, MI, FL, PA, SC, OR, AZ, CO, ND, GA, NE, TX, IL, OH, VT, IN, TN, KY, IA, MT, NY, CA, UT, OK, SD, WA, AK, ME, NV, NM, NC, WV, LA, MN, ID, AL, VA, WI, NH, KS, MA, CT, RI, NJ, MD, MS, WY, DC, DE, HI, AR, ON.

Product description

BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI 2HH-1FM, 138906-01; MINI 3HH-1FG, 169-110; MINI 3HH-1FG, 139091-01; MINI 3HH-1HM, 169-111; MINI 4HH, 138910-01; MINI 4HH, 169-112; MINI 4HM, 169-113; MINI 4HM, 138915-01; TWR MN 10HH-1FH-1FM, 169-23; TWR MN 10HH-2FH, 169-24; TWR MN 10HH-2FH, 138955-01; TWR MN 10HH-2FM, 169-25; TWR MN 10HH-2FM, 138924-01; TWR MN 12HH-1FF, 169-26; TWR MN 12HH-1FF, 138960-01; TWR MN 12HH-1FH, 169-27; TWR MN 12HH-1FH, 138961-01; TWR MN 12HH-1FM, 169-28; TWR MN 12HH-1FM, 138926-01; TWR MN 14HH, 138927-01; TWR MN 14HH, 169-29; TWR MN 1HH-1HM-2FM-4FF, 169-30; TWR MN 2FH-2HM-4FM, 169-31; TWR MN 2HH-10HM-1FM, 169-32; TWR MN 2HH-1FH-5FM, 169-33; TWR MN 2HH-2FH-4FM, 169-34; TWR MN 2HH-4FH-2FM, 169-139; TWR MN 2HH-4HM-4FM, 139125-01; TWR MN 2HH-6FM, 169-38; TWR MN 2HH-6FM, 138919-01; TWR MN 2HH-6HM-3FM, 169-39; TWR MN 2HH-8HM-2FM, 169-40; TWR MN 2HM-6FM, 169-41; TWR MN 3FH-4FM, 169-42; TWR MN 3FH-4FM, 138933-01; TWR MN 3FH-8HH MEDPASS, 169-140; TWR MN 3HH-7HM-2FM, 169-43; TWR MN 4HH-10HM, 169-44; TWR MN 4HH-10HM, 138959-01; TWR MN 4HH-1FH-2HM-3FM, 169-45; TWR MN 4HH-1FH-4FM, 169-46; TWR MN 4HH-1FH-4HM-2FM, 169-47; TWR MN 4HH-2FH-2HM-2FM, 169-49; TWR MN 4HH-2FH-3FM, 169-50; TWR MN 4HH-2FH-3FM, 138931-01; TWR MN 4HH-3FH-2FM, 169-52; TWR MN 4HH-4FH-1FM, 169-53; TWR MN 4HH-4FH-1FM, 138940-01; TWR MN 4HH-4HM-3FM, 169-54; TWR MN 4HH-4HM-3FM, 138952-01; TWR MN 4HH-5FH, 169-55; TWR MN 4HH-5FM, 169-56; TWR MN 4HH-5FM, 138918-01; TWR MN 4HH-6HM-2FM, 169-57; TWR MN 4HM-5FM, 169-59; TWR MN 5HH-3HM-3FM, 169-60; TWR MN 5HH-9HM, 138914-01; TWR MN 5HH-9HM, 169-61; TWR MN 6FH-1FM, 169-62; TWR MN 6HH-1FH-2HM-2FM, 169-63; TWR MN 6HH-1FH-3FM, 169-64; TWR MN 6HH-2FH-2FM, 169-65; TWR MN 6HH-4FH, 169-67; TWR MN 6HH-4FH, 138957-01; TWR MN 6HH-4FM, 169-68; TWR MN 6HH-4FM, 138922-01; TWR MN 6HH-4HM-2FM, 169-69; TWR MN 6HH-8HM, 169-71; TWR MN 6HH-8HM, 138958-01; TWR MN 7FH, 169-72; TWR MN 7FH, 138920-01; TWR MN 7FM, 169-73; TWR MN 7FM, 138937-01; TWR MN 7HH-1HM-3FM, 139086-01; TWR MN 7HH-1HM-3FM, 169-74; TWR MN 8HH-1FH-2FM, 169-75; TWR MN 8HH-2FH-1FM, 169-77; TWR MN 8HH-2HM-2FM, 169-78; TWR MN 8HH-2HM-2FM, 138939-01; TWR MN 8HH-3FF, 169-79; TWR MN 8HH-3FH, 169-80; TWR MN 8HH-3FH, 138956-01; TWR MN 8HH-3FM, 169-81; TWR MN 8HH-3FM, 138923-01. BD PYXIS MEDFLEX MN (Name, REF): 1000 12HH, 139055-01; 1000 2HH-2FM, 139041-01; 1000 2HH-5FM, 139046-01; 1000 4HH-4FM, 139049-01; 1000 6HH-3FM, 139051-01; 1000 8HH-2FM, 139052-01; 2000 8HH-2FH, 139165-01; 2000 8HH-2FM, 139069-01. MEDBANK MAIN, 1137-00; MEDBANK MINI MAIN, 1147-00; MEDBANK TOWER MAIN, 1145-00; MEDFLEX, 1119-00; MEDFLEX 2.0, 1139-00

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

REF/UDI-DI(GTIN)/Software Version: 139088-01/1.2.3.23; 169-137/10885403512544/2.4; 169-101/10885403512544/2.4; 169-102/10885403512544/2.4; 138902-01/2.4; 169-104/10885403512544/2.4; 169-105/10885403512544/2.4; 169-106/10885403512544/2.4; 138908-01/2.4; 169-107/10885403512544/2.4; 138906-01/2.4; 169-108/10885403512544/2.4; 169-110/10885403512544/2.4; 139091-01/2.4; 169-111/10885403512544/2.4; 138910-01/2.4; 169-112/10885403512544/2.4; 169-113/10885403512544/2.4; 138915-01/2.4; 169-23/10885403512568/2.4; 169-24/10885403512568/2.4; 138955-01/2.4; 169-25/10885403512568/2.4; 138924-01/2.4; 169-26/10885403512568/2.4; 138960-01/2.4; 169-27/10885403512568/2.4; 138961-01/2.4; 169-28/10885403512568/2.4; 138926-01/2.4; 138927-01/2.4; 169-29/10885403512568/2.4; 169-30/10885403512568/2.4; 169-31/10885403512568/2.4; 169-32/10885403512568/2.4; 169-33/10885403512568/2.4; 169-34/10885403512568/2.4; 169-139/10885403512568/2.4; 139125-01/2.4; 169-38/10885403512568/2.4; 138919-01/2.4; 169-39/10885403512568/2.4; 169-40/10885403512568/2.4; 169-41/10885403512568/2.4; 169-42/10885403512568/2.4; 138933-01/2.4; 169-140/10885403512568/1.2.3.23; 169-43/10885403512568/2.4; 169-44/10885403512568/2.4; 138959-01/2.4; 169-45/10885403512568/2.4; 169-46/10885403512568/2.4; 169-47/10885403512568/2.4; 169-49/10885403512568/2.4; 169-50/10885403512568/2.4; 138931-01/2.4; 169-52/10885403512568/2.4; 169-53/10885403512568/2.4; 138940-01/2.4; 169-54/10885403512568/2.4; 138952-01/2.4; 169-55/10885403512568/2.4; 169-56/10885403512568/2.4; 138918-01/2.4; 169-57/10885403512568/2.4; 169-59/10885403512568/2.4; 169-60/10885403512568/2.4; 138914-01/2.4; 169-61/10885403512568/2.4; 169-62/10885403512568/2.4; 169-63/10885403512568/2.4; 169-64/10885403512568/2.4; 169-65/10885403512568/2.4; 169-67/10885403512568/2.4; 138957-01/2.4; 169-68/10885403512568/2.4; 138922-01/2.4; 169-69/10885403512568/2.4; 169-71/10885403512568/2.4; 138958-01/2.4; 169-72/10885403512568/2.4; 138920-01/2.4; 169-73/10885403512568/2.4; 138937-01/2.4; 139086-01/2.4; 169-74/10885403512568/2.4; 169-75/10885403512568/2.4; 169-77/10885403512568/2.4; 169-78/10885403512568/2.4; 138939-01/2.4; 169-79/10885403512568/2.4; 169-80/10885403512568/2.4; 138956-01/2.4; 169-81/10885403512568/2.4; 138923-01/2.4; 139055-01/2.4; 139041-01/2.4; 139046-01/2.4; 139049-01/2.4; 139051-01/2.4; 139052-01/2.4; 139165-01/2.4; 139069-01/2.4; 1137-00/2.4; 1147-00/10885403517181/2.4; 1145-00/10885403517167/2.4; 1119-00/10885403512704/2.4; 1139-00/10885403512704/2.4

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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